FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: 2026–2026 ×
1,922 results
601–624 of 1,922
Search insights Median review: 132d Cleared: 99% Top manufacturer: Arthrex, Inc. Lead specialty: Orthopedic
Cleared May 29, 2026
CoSense ETCO Monitor
K253119 · CCJ
Capnia, Inc.
Anesthesiology · 247d
Cleared May 29, 2026
Nexus DRF Digital X-ray Imaging System
K253103 · JAA
Varex Imaging Corporation
Radiology · 247d
Cleared May 29, 2026
Oxygen Concentrator (OX-5A, OX-5C)
K252965 · CAW
Oxytek Medical Technology Co., Ltd.
Anesthesiology · 254d
Cleared May 29, 2026
HistoSonics® Planning Tool
K252947 · QTZ
HistoSonics, Inc.
Radiology · 256d
Cleared May 29, 2026
ZEUS Platform (FG0501US)
K252859 · DQK
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared May 29, 2026
M12 Telemetry System
K252840 · MHX
Global Instrumentation, LLC
Cardiovascular · 266d
Cleared May 29, 2026
Reusable Adult SpO2 Clip Sensor (3m) (M1196A)
K252821 · DQA
Philips Medizin Systeme B?blingen GmbH
Anesthesiology · 267d
Cleared May 29, 2026
Peak Flow Meter (PF-10(BR-PEF231))
K252802 · BZH
Shenzhen Bi-Rich Medical Devices Co.,...
Anesthesiology · 268d
Cleared May 29, 2026
Cryo Sport 2.0 (AVA 501)
K252396 · IRP
Avanutri Equipamentos DE Saúde
Physical Medicine · 302d
Cleared May 28, 2026
ANDI 2.2
K261405 · QIH
Imeka Solutions, Inc.
Radiology · 29d
Cleared May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
K261037 · IZI
Stryker Endoscopy
General & Plastic Surgery · 59d
Cleared May 28, 2026
Ulike Clear Zero (YC10 BU)
K260895 · NFO
Guangxi Ulike Medical Technology Co.,...
Neurology · 71d
Cleared May 28, 2026
Disposable Endoscopic Distal Attachments
K260423 · FDF
Yangzhou Fartley Medical Instrument...
Gastroenterology & Urology · 108d
Cleared May 28, 2026
Helio Kids
K260295 · IOR
Motion Composites
Physical Medicine · 119d
Cleared May 28, 2026
BD BACTEC FXI Culture System
K260213 · MDB
Bd Diagnostic Systems
Microbiology · 125d
Cleared May 28, 2026
Bellalun 2D (VDMS-1000S)
K254092 · MUE
Vieworks Co., Ltd.
Radiology · 160d
Cleared May 28, 2026
Arthrex Bioabsorbable PushLock Suture Anchors
K253931 · MAI
Arthrex, Inc.
Orthopedic · 170d
Cleared May 28, 2026
BMD Titanium Spinal Fusion System
K253894 · MAX
Global Biomedica s.r.o.
Orthopedic · 175d
Cleared May 28, 2026
Trexon™ Monofilament Synthetic Absorbable Suture
K253530 · GAM
Medtronic
General & Plastic Surgery · 196d
Cleared May 28, 2026
Dukal Crepe Paper Sterilization Wrap
K252823 · FRG
Dukal, LLC
General Hospital · 266d
Cleared May 28, 2026
STIMPOD NMS460 Nerve Stimulator
K252712 · GZJ
Algiamed Technologies USA, Inc.
Neurology · 274d
Cleared May 28, 2026
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF,...
K252702 · DQO
Bioptimal International Pte. , Ltd.
Cardiovascular · 274d
Cleared May 28, 2026
Zimmer® Persona® Personalized Knee System
K251840 · MBH
Zimmer, Inc.
Orthopedic · 346d
Cleared May 27, 2026
LigaPASS™ System
K261374 · OWI
Medicrea International S.A.S
Orthopedic · 30d